Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)
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ClinicalTrials.gov Identifier: NCT02962102 |
Recruitment Status :
Completed
First Posted : November 11, 2016
Results First Posted : February 3, 2022
Last Update Posted : February 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critically Ill Acute Kidney Injury | Drug: Calcifediol Drug: Calcitriol Drug: Placebos | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI) |
Actual Study Start Date : | April 3, 2017 |
Actual Primary Completion Date : | July 16, 2020 |
Actual Study Completion Date : | August 6, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Calcifediol
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
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Drug: Calcifediol
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4 |
Experimental: Calcitriol
Calcitriol 4mcg orally daily x 5 days
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Drug: Calcitriol
Calcitriol 4mcg orally daily x 5 |
Placebo Comparator: Placebo
Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days
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Drug: Placebos
Placebo (medium chain triglyceride oil) orally daily x 5 |
- Death Within 7 Days [ Time Frame: 7 days ]All-cause mortality within 7 days following randomization
- Number of Participants Who Received Renal Replacement Therapy Within 7 Days [ Time Frame: 7 days ]Number of participants who received renal replacement therapy within 7 days following randomization
- Relative Average Change in Serum Creatinine From Day 0 to Days 1-7 [ Time Frame: 7 days ]Average percentage change in serum creatinine assessed on days 1-7 as compared to day 0
- Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines [ Time Frame: 7 days ]Any of the following: 1) an increase in serum creatinine ≥50% compared to the immediate pre-randomization value; 2) new or progressive stage of oliguria; or 3) receipt of renal replacement therapy. Oliguria stages 1, 2, and 3 are defined as urine output (UOP) <0.5 ml/kg/h for 6-12h, <0.5 ml/kg/h for >12h, and <0.3 ml/kg/h for ≥24h or anuria for ≥12h, respectively.
- Peak Serum Creatinine (mg/dl) [ Time Frame: 7 days ]Highest serum creatinine value on days 1 to 7
- 28-day Mortality [ Time Frame: 28 days ]All-cause mortality assessed during the 28 days following randomization
- ICU- and Hospital-free Days [ Time Frame: 28 days ]28 minus the number of days in the ICU or hospital, with 0 assigned to patients who die before 28 days
- Kidney Injury - Subgroup Analysis Based on Time Zero 25-hydroxyvitamin D Level Above Versus Below the Median [ Time Frame: 7 days ]Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
- Kidney Injury - Subgroup Analysis Based on the Presence or Absence of AKI on Enrollment [ Time Frame: 7 days ]Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
- Kidney Injury - Subgroup Analysis Based on APACHE II Score on Enrollment Above Versus Below the Median [ Time Frame: 7 days ]Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
- Kidney Injury - Subgroup Analysis Based on ICU Type (Medical Versus Surgical) [ Time Frame: 7 days ]Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
- Kidney Injury - Subgroup Analysis Based on the Presence or Absence of Sepsis on Enrollment [ Time Frame: 7 days ]Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18
- Admitted to the ICU within 48h prior to enrollment
- Likely to remain in the ICU (alive) for ≥72h
- Naso/orogastric tube or ability to swallow
- High risk of severe AKI
Exclusion Criteria:
- Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h
- Currently receiving oral calcium supplementation
- Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days
- AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)
- History of transplantation or receiving chronic (>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)
- Neutropenia in the previous 48h
- Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months
- Receiving cytochrome P450 inhibitors
- Chronic Kidney Disease stage V or End Stage Renal Disease
- Hemoglobin < 7 g/dL
- GI malabsorption
- Prisoner
- Pregnancy or breast feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962102
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David E Leaf, MD, MMSc | Brigham and Women's Hospital |
Documents provided by David Leaf, Brigham and Women's Hospital:
Responsible Party: | David Leaf, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT02962102 |
Other Study ID Numbers: |
2016P002527 5K23DK106448 ( U.S. NIH Grant/Contract ) |
First Posted: | November 11, 2016 Key Record Dates |
Results First Posted: | February 3, 2022 |
Last Update Posted: | February 3, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Kidney Injury Critical Illness Wounds and Injuries Disease Attributes Pathologic Processes Renal Insufficiency Kidney Diseases Urologic Diseases Calcitriol Calcifediol |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Bone Density Conservation Agents |